Prosthetic heart valve with linking element and methods for implanting same

ABSTRACT

Disclosed is a prosthetic heart valve incorporating one or more linking elements adapted for anchoring, aligning, stabilizing, fixing, or otherwise enabling the implantation of other prosthetic devices, including other prosthetic heart valves, in or around the heart.

CLAIM OF PRIORITY

This application is being filed as a non-provisional patent applicationunder 35 U.S.C. §111(b) and 37 CFR §1.53(c). This application claimspriority under 35 U.S.C. §111(e) to U.S. provisional patent applicationSer. No. 61/835,710 filed on Jun. 17, 2013, the contents of which areincorporated herein by reference.

TECHNICAL FIELD

This invention relates generally to prosthetic heart valves and inparticular to prosthetic heart valves incorporating one or more linkingelements adapted for anchoring, aligning, stabilizing, fixing, orotherwise enabling the implantation of other prosthetic devices,including other prosthetic heart valves, in or around the heart.

BACKGROUND OF THE INVENTION

The function of the four valves in the mammalian heart (including thatof humans) is to enable forward propulsion of blood withoutregurgitation, or backwards flow. The valves sit in between the chambersof the heart and its great vessels. The left heart pumps oxygenatedblood under high pressure to the systemic circulation, while the rightheart pumps deoxygenated blood under lower pressure to the pulmonarycirculation.

The left and right heart each have two valves: the atrioventricularvalves, and the semilunar valves. In the left heart, these are themitral and aortic valves, respectively. In the right heart, these arethe tricuspid and pulmonic valves. The atrioventricular valves dividethe atria (low pressure filling chambers) from the ventricles (muscularpumping chambers). The semilunar valves separate the ventricles fromtheir outflow great vessels.

Focusing for now on the cardiac cycle of the left side of the heart, thenormally functioning mitral (atrioventricular) valve opens to permit theleft atrium to empty under low pressure into the relaxed left ventricleduring diastole. At the onset of ventricular systole, rising pressure inthe left ventricle closes the mitral valve, so that blood does not flowback into the left atrium. When left ventricular pressure rises toexceed that in the aorta, the aortic (semilunar) valve opens to permitleft ventricular ejection of blood into the aorta. When the leftventricle has completed its ejection phase, and begins to relax, theaortic valve falls closed, preventing blood from regurgitating into theleft ventricle. During isovolumic relaxation, the ventricular pressurefalls with both aortic and mitral valves closed. Then the mitral valveopens allowing left atrial emptying again into the low pressure leftventricle, and pressure-volume cycling begins again. A similar sequencetakes place in the right heart with its tricuspid and pulmonic valves,right atrium and ventricle, and pulmonary artery.

The cardiac valves in humans may be affected by a variety of congenitaland acquired disorders. The functional result of these disorders mayinclude:

1. Valvular stenosis, whereby a failure of the valve to open completelycauses increased resistance to blood flow across that valve.

2. Valvular regurgitation, whereby failure of the valve (or associatedstructures) to close completely permits blood to leak backwards into thenormally protected chamber.

The consequences of valvular stenosis and regurgitation produce majorhuman disease, including congestive heart failure, adverse remodeling ofthe cardiac chambers, disabling symptoms, heart rhythm disturbances,decreased functional capacity, and death. For these reasons, medicalscience includes treatments to repair, to replace, or to supplementabnormally functioning heart valves.

One strategy to treat malfunctioning heart valves is to implant into theheart a prosthetic valve which supplements or replaces the functions ofthe diseased valve. For example, the transcatheter implantation of aprosthetic valve into the position of the aortic, or the pulmonic valve(the semilunar valves) has been used successfully to treat both stenosisand regurgitation of these valves. In many such applications, thetranscatheter valve is implanted without removing the diseased ormalfunctioning semilunar valve; in this way the malfunctioning valve'stissue is excluded from the main path of blood flow, and its function ispartially or wholly replaced by the new valve. In addition to thetreatment of diseased native valves, prosthetic or transplanted heartvalves can also be treated in this fashion.

The structure and function of the semilunar valves differ importantlyfrom those of the atrioventricular valves. Features which aresignificant for purposes of the present disclosure include:

1. The circular or mildly elliptical conformation of tissue, with lowdistensibility, surrounding the semilunar valves.

2. The tubular nature of the ventricular outflow tract (below thesemilunar valves) and of the great vessels (above the semilunar valves).

3. The higher velocity and pressurized nature of flow across thesemilunar valves compared to the atrioventricular valves.

4. The complex three-dimensional structure of the atrioventricularvalves.

For these and other reasons, there is a need in the art for methods anddevices that utilize certain aspects of the semilunar valve complex andits surrounding tissues for the purposes of anchoring, aligning,stabilizing, fixing, or otherwise enabling the implantation ofprosthetic devices into the atrioventricular valve and elsewhere in theheart or in the vicinity thereof.

DETAILED DESCRIPTION OF THE INVENTION

While the present invention will be described more fully hereinafter, itis to be understood at the outset of the description which follows thatpersons of skill in the appropriate arts may modify the invention hereindescribed while still achieving the favorable results of this invention.Accordingly, the description which follows is to be understood as beinga broad, teaching disclosure directed to persons of skill in theappropriate arts, and not as limiting upon the present invention.

The herein disclosed invention describes, among other embodiments, aprosthetic heart valve, for example in the semilunar valve position,incorporating one or more linking elements adapted for anchoring,aligning, stabilizing, fixing, or otherwise enabling the implantation ofother prosthetic devices, including other prosthetic heart valves, in oraround the heart.

There are many examples of prosthetic heart valves known in the priorart, all of which are suitable for adaptation to the linking elementsdescribed in the present disclosure. Among those devices are, forexample, the prosthetic semilunar heart valves described in U.S. Pat.Nos. 7,585,321, 7,846,203, 7,846,204, 6,908,481, 8,002,825, 8,057,540,8,579,966, 8,591,575, and 8,721,708 as well as U.S. Patent ApplicationPublication Nos. 201100036485 20140163672, and 20140005774, all of whichare incorporated by reference in the present disclosure.

In one embodiment, the invention encompasses the use of a linkingelement between a prosthetic device in the position of the semilunarvalve, and a prosthetic device in the position of the atrioventricularvalve.

In one such embodiment, a transcatheter-implanted aortic valve isphysically connected by one or more mechanical linking elements to animplanted mitral valve. The one or more linking elements provide ananchor and additional stability to the implanted mitral valve andadditionally may provide for better alignment of the implanted mitralvalve relative to the annulus of the native mitral valve and to theother structures of the native mitral valve apparatus.

In another such embodiment, a transcatheter-implanted pulmonic valve isphysically connected by one or more mechanical linking elements to animplanted tricuspid valve, providing similar stability and alignmentbenefits.

In some embodiments of the present invention, the described fixationelements may supplement other alignment or fixation components toimprove the positioning, and/or stability of an implanted device.

In another embodiment of the present invention, components other than animplanted heart valve are connected to an implanted semilunar valve byone or more mechanical linking elements. These components may beconnected to the implanted semilunar valve in addition to, or insteadof, a second implanted heart valve.

The additional components may include devices that perform functionswithin the heart other than to control blood flow between the variouschambers of the heart and/or blood vessels. For example, such componentsmay include devices involved in electrically stimulating the heart (suchas pacemakers and implanted defibrillators). Such components may alsoinclude components of a cardiac assist pump and/or devices which permitmonitoring of heart function, of intracardiac pressure, of blood flow,or of electrical activity within the heart. Such components may alsoinclude devices which maintain or assist blood flow within the coronaryarteries of the heart, such as stents.

The one or more linking elements of the present invention are formed ofbiocompatible materials that are well known in the relevant art. Suchmaterials can be metallic (stainless steel, silver, gold, titanium,cobalt chromium and other biocompatible metals), plastic polymers,ceramics, or other known biocompatible materials. Said linking elementscan have varying degrees of rigidity depending on the application.

The one or more linking elements of the present invention can be formedas a single piece or may be formed from sub components that can beconnected so as to permit articulation within the link.

The one or more linking elements of the present invention may becomprised of a suture, fiber, cable, or other similar materialpermitting tightening, tensioning, adjusting, and tying of the linkageas needed.

The one or more linking elements of the present invention can beintegrally formed into the implanted semilunar valve or may be removablyattached to the implanted semilunar valve. The connection between thesemilunar valve and one or more linking elements may be rigid, flexibleor articulated (through, for example, a hinged joint, a snap-togetherjoint, a ball-and-socket joint, or similar mechanism) depending on therequired application.

Similarly, the connection between the one or more linking elements, andthe component or components to be anchored or supported by the implantedsemilunar valve may be rigid, flexible or articulated depending on therequired application.

In another embodiment of the present invention, the linking elementutilizes magnetic forces to connect to the implanted semilunar valve orthe device to be anchored thereto. A magnetic connection between thelinking element and the implanted semilunar valve or other device maysignificantly assist in orienting the device and valve relative to eachother.

In a variation of this embodiment, the magnetic force may be exertedacross a distance so that the linked components are not necessarily indirect physical contact with one another.

The advantages for medical science, practitioners, and patients of thedisclosed invention include but are not limited to:

1. Stabilization of an atrioventricular valve prosthesis in itsposition.

2. Orientation of an atrioventricular prosthesis in the desiredposition.

3. Reduction of the forces of annular expansion and distortion imposedon the heart by an atrioventricular valve prosthesis.

4. Accurate positioning of diagnostic or therapeutic elements within theheart.

An embodiment of the present invention can be used through the followingmethod. First an aortic valve prosthesis is implanted into itsphysiologic position, using any of several techniques, including but notlimited to:

-   -   transcatheter retrograde delivery    -   transcatheter anterograde delivery    -   surgical implantation

The aortic valve prosthesis is assembled (either prior to implantation,or subsequent to implantation in the body) with one or more of thelinking elements described, in an attachment to the main structure ofthe device.

To utilize the aortic valve prosthesis with linking element, theoperator connects the secondarily implanted device (for example, amitral valve prosthesis) to the linking element. This connection may beaccomplished by transcatheter capture or the linking element from any ofseveral access approaches, including but not limited to transcatheter(via access retrograde across the aortic valve, transseptal antegradeacross the mitral valve, or from the left ventricle transapical) or anysurgical approach to the heart.

Once the connection between the primary valve and the secondary devicehas been made, the operator completes the implantation of the secondarydevice, utilizing the linking element for its intended purposes ofstabilization, orientation, or fixation of the secondary device.

It will be understood by those having ordinary skill in the art thatalthough in the above description an implanted semilunar valveprosthesis is the base to which an implanted atrioventricular valveprosthesis, or other device is anchored to, a reciprocal arrangement isalso comprehended by the present invention. That is, an implantedatrioventricular valve prosthesis may serve as the base to which animplanted semilunar valve prosthesis, or other device, is anchored.

Accordingly, it will be understood that several embodiments of thepresent invention have been disclosed by way of example and that othermodifications and alterations may occur to those skilled in the artwithout departing from the scope and spirit of the appended claims.

What is claimed is:
 1. A prosthetic heart valve assembly comprising: animplantable prosthetic cardiac valve configured to permit blood flow ina first direction and to inhibit blood flow in a second directionopposite the first direction; a radially collapsible and expandableannular support frame supporting said prosthetic cardiac valve; one ormore linking elements connected to said support frame, each having aterminal end extending distally from said support frame; wherein each ofsaid terminal ends is adapted to connect to a heart implantable device;and wherein the connection between the support frame and at least one ofsaid linking elements is magnetic.
 2. The prosthetic heart valveassembly of claim 1, wherein said implantable prosthetic cardiac valveis a valve prosthesis selected from the group consisting of an aorticvalve prosthesis, a pulmonic valve prosthesis, a mitral valve prosthesisand a tricuspid valve prosthesis.
 3. The prosthetic heart valve assemblyof claim 1, wherein said heart implantable device is a device selectedfrom the group consisting of an aortic valve prosthesis, a pulmonicvalve prosthesis, a mitral valve prosthesis, a tricuspid valveprosthesis, and components thereof.
 4. The prosthetic heart valveassembly of claim 1, wherein said heart implantable device is a deviceselected from the group consisting of an aortic valve prosthesis, apulmonic valve prosthesis, a mitral valve prosthesis, a tricuspid valveprosthesis, a pacemaker, a defibrillator, a cardiac assist pump, a bloodflow monitor, an electrical activity monitor, a stein, and componentsthereof.
 5. The prosthetic heart valve assembly of claim 1 wherein atleast one of said one or more linking elements is formed at leastpartially of a biocompatible material selected from the group consistingof stainless steel, silver, gold, titanium, cobalt chromium, plasticpolymer, pyrolytic carbon, suture, fiber, filament, cable andcombinations thereof.
 6. The prosthetic heart valve assembly of claim 1wherein at least one of said one or more linking elements comprises asingle component.
 7. The prosthetic heart valve assembly of claim 1wherein at least one of said one or more linking elements comprises aplurality of subcomponents in an articulated arrangement.
 8. Theprosthetic heart valve assembly of claim 1 wherein at least one of saidone or more linking elements is rigid.
 9. The prosthetic heart valveassembly of claim 1 wherein at least one of said one or more linkingelements is flexible.
 10. The prosthetic heart valve assembly of claim 1wherein the connection between said support frame and at least one ofsaid one or more linking elements is rigid.
 11. The prosthetic heartvalve assembly of claim 1 wherein the connection between said supportframe and at least one of said one or more linking elements isarticulated.
 12. The prosthetic heart valve assembly of claim whereinthe connection between said support frame and at least one of said oneor more linking elements is flexible.
 13. The prosthetic heart valveassembly of claim 1 wherein at least one of said terminal ends isadapted to connect to said heart implantable device using an articulatedjoint.
 14. The prosthetic heart valve assembly of claim 1 wherein atleast one of said terminal ends is adapted to connect to said heartimplantable device using a magnetic joint.
 15. The prosthetic heartvalve assembly of claim 1 wherein at least one of said one or morelinking elements is adjustable by tightening, loosening, rotating orredirecting.
 16. A linking element connecting heart implantable devicescomprising: an elongated component having a first terminal end and asecond terminal end; wherein said first terminal end is adapted toconnect to a first heart implantable device; wherein said secondterminal end is adapted to connect to a second heart implantable device;and wherein at least one of said first terminal end or said secondterminal end are adapted to connect to one of said first heartimplantable device or second heart implantable device using a magneticjoint.
 17. The linking element of claim 16 wherein at least one of saidfirst heart implantable device and said second heart implantable deviceare selected from the group consisting of an aortic valve prosthesis, apulmonic valve prosthesis, a mitral valve prosthesis, a tricuspid valveprosthesis, a pacemaker, a defibrillator, a cardiac assist pump, a bloodflow monitor, an electrical activity monitor, a stent, and componentsthereof.
 18. The linking element of claim 16 wherein said linkingelements is formed at least partially of a biocompatible materialselected from the group consisting of stainless steel, silver, gold,titanium, cobalt chromium, plastic polymer, pyrolytic carbon, suture,fiber, filament, cable and combinations thereof.
 19. The linking elementof claim 16 wherein said linking element comprises a plurality ofsubcomponents in an articulated arrangement.
 20. The linking element ofclaim 16 wherein said linking element is rigid.
 21. The linking elementof claim 16 wherein said linking element is flexible.
 22. The linkingelement of claim 16 wherein said linking element is adjustable bytightening, loosening, rotating or redirecting.
 23. The linking elementof claim 16 wherein at least one of said first terminal end said secondterminal end are adapted to connect to one of said first heartimplantable device or second heart implantable device using anarticulated joint.
 24. A prosthetic heart valve assembly comprising: atimplantable prosthetic cardiac valve configured to permit blood flow ina first direction and to inhibit blood flow in a second directionopposite the first direction; a radially collapsible and expandableannular support frame supporting said prosthetic cardiac valve; one ormore linking elements connected to said support frame, each having, aterminal end extending distally from said support frame; wherein each ofsaid terminal ends is adapted to connect to a heart implantable device;and wherein at least one of said terminal ends is adapted to connect tosaid heart implantable device using a magnetic joint.
 25. The prostheticheart valve assembly of claim 24, wherein said implantable prostheticcardiac valve is a valve prosthesis selected from the group consistingof an aortic valve prosthesis, a pulmonic valve prosthesis, a mitralvalve prosthesis and a tricuspid valve prosthesis.
 26. The prostheticheart valve assembly of claim 24, wherein said heart implantable deviceis a device selected from the group consisting of an aortic valveprosthesis, a pulmonic valve prosthesis, a mitral valve prosthesis, atricuspid valve prosthesis, and components thereof.
 27. The prostheticheart valve assembly of claim 24, wherein said heart implantable deviceis a device selected from the group consisting of an aortic valveprosthesis, a pulmonic valve prosthesis, a mitral valve prosthesis, atricuspid valve prosthesis, a pacemaker, a defibrillator, a cardiacassist pump, a blood flow monitor, an electrical activity monitor, astem, and components thereof.
 28. The prosthetic heart valve assembly ofclaim 24, wherein at least one of said one or more linking elements isformed at least partially of a biocompatible material selected from thegroup consisting of stainless steel, silver, gold, titanium, cobaltchromium, plastic polymer, pyrolytic carbon, suture, fiber, filament,cable and combinations thereof.
 29. The prosthetic heart valve assemblyof claim 24, wherein at least one of said one or more linking elementscomprises a single component.
 30. The prosthetic heart valve assembly ofclaim 24, wherein at least one of said one or more linking elementscomprises a plurality of subcomponents in an articulated arrangement.31. The prosthetic heart valve assembly of claim 24, wherein at leastone of said one or more linking elements is rigid.
 32. The prostheticheart valve assembly of claim 24, wherein at least one of said one ormore linking elements is flexible.
 33. The prosthetic heart valveassembly of claim 24, wherein the connection between said support frameand at least one of said one or more linking elements is rigid.
 34. Theprosthetic heart valve assembly of claim 24, wherein the connectionbetween said support frame and at least one of said one or more linkingelements is articulated.
 35. The prosthetic heart valve assembly ofclaim 24, wherein the connection between said support frame and at leastone of said one or more linking elements is flexible.
 36. The prostheticheart valve assembly of claim 24, wherein the connection between saidsupport frame and at least one of said one or more linking elements ismagnetic.
 37. The prosthetic heart valve assembly of claim 24, whereinat least one of said terminal ends is adapted to connect to said heartimplantable device using an articulated joint.
 38. The prosthetic heartvalve assembly of claim 24, wherein at least one of said one or morelinking elements is adjustable by tightening, loosening, rotating orredirecting.